TR201802144T4 - Tissue anchorage for anuloplasty device. - Google Patents

Abstract

TISSUE ANCHORAGE FOR ANULOPLASTY DEVICE Some embodiments of the present invention generally relate to tissue anchors. More particularly, some embodiments of the present invention relate to tissue anchors for the repair of an atrioventricular valve of a patient.

Description

TISSUE ANCHORAGE FOR ANULOPLASTY DEVICE ww Some applications of the present invention relate to tissue anchors in general. more private As a result, some applications of the present invention are used to ensure that a patient has an atrioventricular valve. relates to tissue anchors for repair.

BACKGROUND OF THE INVENTION Dilatation of the annulus of the mitral valve is when the valve leaflets are completely closed with the valve closed. prevents them from becoming cooperative. Mitral canine from the left ventricle into the left atrium failure can lead to an increase in total heartbeat volume and a decrease in cardiac output, and Eventually, the left ventricle collapses due to excessive volume and pressure overload in the left atrium. leads to its weakening.

US-A-2004/0236419 to reconstruct an atrioventricular heart valve describes methods, these methods regenerate a heart valve that has somehow become inadequate. Partial or full annuloplasty rings proportioned to configure, one pair spaced along its length with trigonal suture or implantable anchors and ring may have pairs of feet sized and shaped for attachment in they can use systems with many clamps. These systems are relative between the clamps and the ring. they allow axial movement, so that a patient's heart valve It can be reconfigured in a way that does not prevent minor changes of its components.

In case of shape memory alloy material clamps, after implantation, the clamped free feet with tips can be found. Annuloplasty rings can be full or partial and can be fenestrated. they may be. An alternative method is to use a flexible wire, preferably of shape-memory material. runs through the folds of pre-implanted clamps. Other alternative systems hooked ends to engage with clamps or other implanted supports They use connectors from shape-memory material found in they are then shortened in effective length and They pull the clamps or other supports towards each other to form the curvature. This fasteners may be separate from or integrated with supports and may take various forms and They can have forms. Many of these systems are invasive using a delivery catheter. non-implantable_ US-A-2007/0049942 between the first and second parts of a soft body tissue structure describes the remodeling of this tissue structure by shortening the distance. first and The second anchor structures are implanted into the first and second portions of the tissue structure, respectively. they are made. These anchor structures are connected by a bonding structure, the anchorage of this anchoring structure the length between the structures in such a way as to pull the tissue structure parts towards each other. can be shortened. Anchor structures may each contain two screw structures, these screw structures are one a spacer between the two screws and into the transverse portions of the tissue structure to the anchoring structure. they are driven with. If desired, the entire prosthesis can be implanted percutaneously. Your prosthesis An exemplary use is that at least a portion of the prosthesis is inserted into a patient's coronary sinus. It is the shortening of the annulus of the patient's mitral valve while implanted. The following Patents and patent application publications may be helpful: PCT Publication WO 07/136783 by Cartledge et al.

PCT Publication WO 08/068756 (US-A-2008/262609) of Gross et al., available Describes a tissue anchor as in the preamble of claim 1 of the invention.

PCT Publication WO 10/004546 by Gross et al.

PCT Publication WO 10/073246 by Cabiri et al.

US-5,306,296 to Wright et al.

US-6,569,198 Wilson et al.

US-6,619,291 of Hlavka et al.

US-6,764,510 to Vidlund et al.

US-7,004,176 of Lau.

US-7,101,395 of Tremulis et al.

US-7,175,660 of Cartledge et al.

US 2003/0050693 to Quijano et al.

US 2003/0167062 to Gambale et al.

US 2004/0024451 to Johnson et al.

US 2004/0148021 Cartledge et al.

US 2005/0171601 to Cosgrove et al.

US 2005/0288781 Moaddeb et al.

US 2007/0016287 to Cartledge et al.

US 2007/0010188 to Spence et al.

US 2007/0219558 of Deutsch.

US 2007/0282375 by Hindrichs et al.

US 2008/02262609 Gross et al.

US 2010/0161041 to Maisano et al.

US 2010/0161042 Maisano et al.

US 2010/0211166 by Miller et al.

The following articles may be helpful: O'Reilly S et al, "Heart valve surgery pushes the envelope," Medtech lnsight 8(3): 73, 99-108 (2006) Dieter RS, "Percutaneous valve repair: Update on mitral regurgitation and endovascular approaches to the mitral valve," Applications coarse Imaging, Cardiac Interventions, Supported by an educational grant from Amersham Health pp. 11-14 (2003) 2 SUMMARY OF THE INVENTION The invention is a tissue anchor for use with a valve repair implant according to claim 1. it provides. Optional features of the invention are set out in dependent claims. Available In some embodiments of the invention, the recipient of an implant and its implantation A tissue anchor is provided in a structure that facilitates it. Anchor, for example, that penetrates a patient's tissue includes a distal tissue anchor such as a helical anchor. The anchor is also connected to the implanted area and a proximal insertion element to the implant that facilitates the attachment of the implant to the tissue anchor includes. the inserting element, the proximal tip and the distal tissue connector Contains a stalk that extends from its proximal end. For some applications, the implanted The proximal tip of the member includes a hook that pierces and receives the implant.

Typically, during an open heart, minimally invasive, or transcatheter procedure, the patient's Multiple tissue anchors are implanted through an annulus of an atrioventricular valve and this tissue anchors, a valve repair implant, for example an annuloplasty ring or a They have a structure that takes the prosthetic cover and facilitates its implantation. Each of your anchors one is attached to a cord, such as a suture or a it is connected to the wire in a detachable way. Prior to implantation of the valve repair implant, each the cord is passed through the implant and then the implant moves along the cords into the annulus. is shifted. In response to the constant pushing of the valve repair implant, after the implant, The proximal spikes of each of the implant-receiving members are drilled at locations corresponding to them.

The physician continues to push the valve repair implant so that the implant elements and slides along the shanks of the anchors. Implant, each of the elements entering the implant until the proximal spikes of one are exposed through the lumen of the valve repair implant and It is pushed along the handle until it is located proximally on a proximal surface of the implant. Then, The valve repair implant is fixed on the implant surface facing the lumen of the patient's atrium.

After the implant is fixed, the cords are separated from the anchors and the patient's body is extracted from it. An atrioventricular valve repair implant in a patient of a tissue anchorage The method of implanting it on the does not take.

In some embodiments of the present invention, a proximal attachment to a proximal portion of the anchor stem the limiting element, for example, arms that can expand in the radial direction are attached. This anger element prevents the implant from separating from the inserting element.

In some embodiments of the present invention, a flexible portion, for example a tension spring, may be used in the proximal from the proximal cusp of the implanting element, and from the distal end to the proximal tip of the stem. it is attached to the end.

The invention provides a device according to claim 1.

In some embodiments of the present invention, the length of the handle is between 1 mm and 7 mm and the most the largest cross-sectional area is between 0.03 mm2 and 0.2 mm2, this length is the square of the largest cross-sectional area at least 4 times the root.

The present invention is detailed below of the applications of the invention discussed together with the drawings. It will be perfectly clear from the description, here: BRIEF DESCRIPTION OF THE DRAWINGS Figures 1A-F show a valve repair implant in accordance with some embodiments of the present invention. schematic of a procedure for implanting a tissue anchor to receive are representations; Figures 2A-C illustrate tissue anchorage and its delivery in accordance with some embodiments of the present invention. are the sematic representations of the agent; Figure 3 shows several textures in Figures 2A-C, in accordance with some embodiments of the present invention. schematic of the anchor implanted through a patient's annulus is the display; Figure 4 shows how a valve repair implant is constructed in accordance with some embodiments of the present invention. Figure 3 is a schematic representation of the advancement of several tissue anchors; Figures 5A-B, 6A-B and 7 are illustrated in Figures 3-4, in accordance with some embodiments of the present invention. schematic representations of the respective locking mechanisms for each of the tissue anchors; Figures 8 and 9 show the texture of Figures 3-4, in accordance with some applications of the present invention. are the schematic representations of the valve repair implant Samples taken with their anchors; Figure 10 shows a valve repair implant in accordance with some embodiments of the present invention. schematic representation of a tissue anchor for receiving; Figures 11A-D show several textures in Figure 10, in accordance with some embodiments of the present invention. schematic representations of a transcatheter procedure for implantation of the anchor; Figures 12-14 show a minimally invasive or implantation of tissue anchors in Figures 2A-C and 10 during the open heart procedure are sematic representations of a router for; Figures 15-18 show a minimally invasive or implantation of the valve repair implant during the open heart procedure and sematic representations of its fixation; Figure 19 shows the texture of Figures 2A-C, in accordance with some embodiments of the present invention. schematic representation of the anchor; and Figure 20 illustrates the tissue anchorage of Figure 10 in accordance with some embodiments of the present invention. sematic representation.

DETAILED DESCRIPTION OF APPLICATIONS Here, in accordance with some embodiments of the present invention, a tissue anchorage 49 Referring to Figures 1A-F, 2A-C and 3, 20 sematic representations of a system for implantation is found. Figures 1A-F, a transcatheter procedure for implantation of tissue anchor 49 shows. Figures 2A-C of a patient at an implantation site, as seen for example in an annular 25 of the heart 22, the anchor 49 for its proper conduction and implantation in this region. indicates a transcatheter delivery device 42 . Typically, the implantation site is a an atrioventricular valve, for example a mitral valve or a tricuspid valve contains the annulus. the implantation site is not limited to a patient's heart valve, and anchorage in other tissues of 49 patients, for example, in a part of the inner wall of the patient's heart, in the stomach of the patient, etc. It should be noted that it can be implanted. As seen in Figure 2B tissue anchor 49, a distal tissue anchor 50, for example a helical tissue anchor 58 and includes a proximal element 47a that engages the implant. The proximal element 47a entering the implant is stem 52a and, as described below, puncture a portion of the valve repair implant and the through structure includes a proximal implant restraint member 53a. proximal restriction member 53a (ie, a portion of the implanting member 47a), through which a passage 56 in descriptive form. A cord 54 can be threaded through the passage 56 into the anchor 49 so that it can be disengaged. it connects. Cord 54 is attached to the implanted tissue anchorage of the valve repair implant 25 in the annulus. 49 serves to facilitate its correct orientation.

Here, in accordance with some embodiments of the present invention, we describe a patient's mitral valve. schematic of a procedure for the implantation of multiple tissue anchors 49 to repair Reference is made to Figures 1A-F, 2A-C, and 3-4, which are illustrations. Mitral valve 24 leaflets 26 It is shown with 28 included. The procedure typically includes fluoroscopy, transesophageal echo, and/or It is performed with the help of imaging methods such as echocardiography.

The procedure is typically performed on the right side of 32 patients with a semi-rigid guide wire as seen in Figure 1A. It begins with its advancement into the atrium.

As shown in Figure 1B, the guide wire 32 of a sheath 34 along the guide wire 32 and the right Provides a guideline for its subsequent progression into the atrium. When sheath 34 enters the right atrium The guide wire 32 is withdrawn from the patient's body. Sheath 34 typically includes a 14-20 F sheath, however, the size can be chosen appropriately for a particular patient. Kilif 34 is typically right through the vasculature using an appropriate starting point for the patient. advanced into the atrium. For example: - sheath 34 right into the patient's femoral vein through the inferior vena cava 30 transseptal into the atrium and typically through the fossa ovalis, into the left atrium can be inserted via; . sheath 34 into the basilic vein of the patient, through the subclavian vein, into the superior vena cava, into the right atrium and typically through the fossa ovalis, into the left atrium can be inserted transseptally; or . sheath 34 into the neck vein, through the subclavian vein, into the superior vena cava, into the right atrium and typically through the fossa ovalis, into the left atrium can be inserted transseptally.

In some embodiments of the present invention, sheath 34 is typically designated for a particular patient. the patient's inferior vena cava 30 (as seen) using an appropriate starting point It is advanced through it and into the right atrium.

(In this context, in the description and claims, the "proximal" system 20 is introduced into the patient's body.) closer to the orifice where it was originally placed, and "distal" means farther from that orifice.) Sheath 34 is advanced distally until it reaches the interatrial septum, as seen in Figure 1C.

A flexible needle 38 and a diator attached to an elongated wire 36, as seen in Figure 1D. (not shown) is advanced through the sheath 34 and into the heart 22 . Kilifi 34 into the left atrium To advance transseptally, the diator is advanced to the septum and the needle 38 is pushed through the dilator. and, passing the dilator and then the cilia 34 through it and into the left atrium. It is allowed to puncture the septum to create an opening that facilitates it. In the dilator septum is passed through the hole created with the needle. Typically, the diator is hollow for passage through the needle 38 is of the form that defines a pipe shaft, and a hollow pipe shaft defines a tapering distal end form. First, this tapering distal tip is advanced with the needle 38 through the hole created.

As the increasing diameter of the distal end of the dilator is pushed through the hole in the septum, the hole is enlarged.

Progress of the sheath 34 within the septum and into the left atrium, as seen in Figure 1E. Removing the dilator and needle 38 from inside the sheath 34 follows.

Subsequently, the delivery device 42 is in an advancement catheter 40 and is advanced through sheath 34. A transmission medium 42 is connected to a router 44 from a distal end. The extended pipe includes shaft. Router 44 releasably engages anchor 49 and anchors 49 It is delivered to the left atrium and subsequently anchored to the patient's annulus 25 tissue. facilitates its implantation. The means of transmission 42 is described with reference to Figures 2A-C below.

Figure 2A shows the delivery device 42 inserted into the advancing catheter 40, advancing The catheter 40 slides through the sheath 34 and into the annulus 25 of the heart 22. transmission medium 42, guide 44 and anchor 49 are shown in section.

Figure 28 shows the relative spatial configurations of the transmission medium 42, the router 44, and the anchor 49. shows. Anchor 49 has a needle-like distal spike 51 in the structure that pierces the patient's tissue. 6 includes a distal tissue connector 50. Distal tissue connector 50, through sample and includes, without limitation, a helical tissue anchor 58, eg tissue connector 50 any suitable tissue known in the art (eg as seen in Figures 19 to 20 below) may contain anchorage. For example, the distal tissue connector 50 may be any suitable known in the art. a tissue anchor (eg with a spiral or a Screw shaft) or of Gross et al., With the title "Annuloplasty devices and methods of delivery therefor", on June 15, 2009 as described in PCT Patent Application No. PCT/IL2009/000593 filed any tissue may contain anchorage.

Reference is made here to Figures 2A-B. 58 helical helices of the helical tissue anchor they form an essentially cylindrical helix enclosing a lumen of the tissue anchor 58 .

The helical tissue anchor 58 provides a rod 55 that protrudes into its lumen. form. A portion of the insert 47a distal to the implant 57 is attached to the rod 55, for example is welded.

Reference is also made to Figure 2B. Distal tissue connector 50 and implant insertion element The length L1 of the anchor 49 containing 47a is 6-18 mm, for example 6-12 mm, for example 10 mm.

In some embodiments of the present invention, the distal tissue connector 50 and the implant insertion element 47a are separate parts connected to each other, eg welded. Alternatively, distal tissue The connecting element 50 and the implant inserting element 47a are manufactured from a single piece. implant length L2 of the entering element 47a is 4-10 mm, for example 5.5 mm. Distal tissue connection The length of element 50 L3 is 2-8 mm, for example 4 mm. The inserting element 47a is a the stem 52a and the proximal limiting member 53a.

The length of the handle 52a is between 1 mm and 7 mm, for example 5.5 mm and (52a of the handle with the widest cross-sectional area of 0.03 mm2 (measured in a plane perpendicular to the axis on which the length is measured) It is between 0.2 mm2, for example 0.13 mm2. The length here is the largest cross-sectional area. is at least 4 times the square root (for example, 5, 8 or 10 times). The largest in the 52a section of the sap the size is between 0.2 mm and 0.5 mm (for example, 0.4 mm). So, for example, sapin 52a its length is 5.5 mm and (measured in the plane perpendicular to the axis from which the length of the handle 52a is measured) the largest section size is 0.4 mm. In such an example, the length to the largest cross-sectional dimension rate is approximately 13.7511. In some applications, this ratio is between 521 and 14:1. depending on the size of the implant attached to the patient's tissue via anchor 49 changes.

Anchors 49 can be applied to any tissue of any size suitable for any tissue of the patient. The largest cross-section of the handle 52a length can be used to implant the implant. ratio of 521 to 14:1, depending on the size of the implant attached to the patient. It should be noted that between

Proximal limiting member 53a within 2 mm of the proximal end of the stem 52a to the stem 52a may or may not be connected. As mentioned above, in some applications, member 47a includes proximal limiting member 53a. 53a of the proximal limiting element in cross section (measured in a plane perpendicular to the axis from which length L1 is measured) the largest dimension is 0.3 mm to 0.75 mm, for example 0.6 mm. 53a of the proximal limiting element wide cross-sectional area between 0.07 mm2 and 0.44 mm2 (for example, 0.28 mm), ie 52a of the stem at least 1.5 times the widest cross-sectional area. The valve repair implant will be explained below. After its subsequent implantation, proximal limiting member 53a is implanted stem 52a. glide proximally along and detach from the implanting element 47a. obstacles. the implant inserting element 47a, the implant insertion and 53a through the lumen of the implant so that it lies proximal to the outer surface of the implant. providing an extended penetration with a sufficient length-to-width ratio to pass form. In this configuration, the proximal limiting element 53a, as described below prevents the implant from separating from the implant inserting element 47a.

The proximal limiting element 53a is of the form defining a passage 56 through this passage. within 1 mm of a proximal end of the inserting element 47a, for example, within 0.5 mm there are at least two openings. The cord 54 is looped through the passage 56 and thus attached to the anchor 49 it is connected in a dissolvable way. As seen in Figure 2C, 54 proximal limitation of the cord The two portions of element 53a protruding beyond passage 56, a single strand 54 proximal end in the proximal region 49 to the tissue anchorage to form part 59, for example the patient's they are joined together in an area outside of their body, for example welded. Finally, Ability to slide the implant along the cord 54 and into the 25 tissue anchors 49 in the annulus For this, the end portion 59 of the cord 54 is passed through the implant outside the patient's body. implant When implanted in the patient's annulus, the cord 54 is distal to the single proximal end portion 59. is cut so that the loop formed by joining two parts of the cord 54 at the end 59 breaks off. When cord 54 is cut, passage of proximal restraining member 53a of cord 54 56 The physician withdraws the proximal end 59 until it is pulled through and disconnected from the anchor 49 and removes the cord from the body of 54 patients.

Reference is also made to Figure 2A. As seen in the sectional illustration, both the transmission medium 42 and deflector 44 is connected to the proximal limiting member 53a of the implanting member 47a. They are in the form that defines a central lumen for the cord 54, which is Cord 54, typically a flexible and/or super-flexible material, eg nitinol, ePTFE, PTFE, polyester, It consists of a wire, a ribbon, a string or a band containing stainless steel or cobalt chromium. Available In some embodiments of the invention, the cord 54 includes a braided polyester suture (eg, TiCron).

In some embodiments of the present invention, the cord 54 is covered with polytetrafluoroethylene (PTFE).

In some embodiments of the present invention, the cord 54 is interlocked to form a rope structure. The coil contains many wires.

The router 44 is located at a distal end of the pipe shaft 42 of the transmission medium and its outer diameter a distal applicator smaller than the outer diameter of a proximal portion of the router 44 section 46 is provided. Anchor 49 with Router 44 Cross section in Figure 2A As seen in the illustration, the distal applicator portion 46 is one of the distal tissue connector 50 It is shaped to fit into its lumen (ie, the outer diameter of the portion 46 is 50 of the distal tissue connector. smaller than the inside diameter). Router 44 is in the form that defines a slot 48, this slot 48 divides the distal end portion of the router 44 into two lateral wall portions. Slit 48, (Fig. 2A) to house the implanting element 47a and connect it to the delivery means 42 it acts as a casing to bind it in a detachable way. Slit 48, anchor 49 annulus 25 Holds anchor 49 in place as it is advanced forward. Next, the delivery vehicle 42 is attached to the anchor 49 distal tissue. it functions to implant the fastener 50 into the tissue of the annulus 25 . First, the transmission A torque is supplied to the diverter 44 in response to the rotation of the pipe shaft 42 of the vehicle.

Corresponding to the torque, the lateral wall at the distal portion of the steerer 44 distal applicator section 46 with sections, helical tissue anchorage with implant-receiving element 47a 58 acting as a screwing tool by applying a circular force.

As seen in Figure 2A, rod 55 of the distal tissue connector 50, rod 55 taken and inserted into the slot 48 and with the lateral wall portions of the router 44 when coiled, anchor 49 acts as a tie to router 44.

Figure 3 is implanted in the corresponding portions of the annulus 25 tissue along the circumference of the annulus 25. shows many anchors 49 that have been made. Each of the anchors 49 has a central the longitudinal axis is approximately 45 degrees to 90 degrees with the surface of the annulus 25 tissue. between, for example, about 75 degrees to 90 degrees, for example, about 90 degrees It is implanted to form an angle. The physician described each of the anchors 49 above. conduction to advance systematically through the blade 34 and into the annulus 25 as uses tool 42. A first anchor 49 is attached to the router 44 of the transmission medium as follows: (a) cord 45 is through the lumen of the pipe shaft 42 of the transmission medium and of the diverter 44 and (b) the distal applicator portion 46 of the router 44 helical tissue it is advanced within the 58 lumen of the anchor, (o) while the 58 rod of the helical tissue anchor 55 the router 44 is advanced to its place in slot 48. Anchor 44 of the router with anchor 49 Their relative spatial configurations when 49 are connected to router 44 are shown in Figure 2A above. shown with reference.

The delivery device 42 is then fed into the advancement catheter 40 and a distal end of the catheter 40 Catheter 40 until exposed through the distal end of sheath 34 and into the patient's left atrium. The sheath is advanced towards the annulus 25 within 34. Advance catheter 40 through the annulus 25 advances to the position. Subsequently, the pipe shaft 42 of the conveying medium, 58 of the helical tissue anchor the distal tip 51 is pushed against the surface of the annulus tissue. Then, physician transmission by rotating the pipe shaft of the tool 42 about a central axis of the tool 42, 44 torque is given. This turn of the vehicle 42 rotates the router 44 so that the distal wall portions of the distal end of the guide 44 are attached to the helical tissue anchor 58 with a circular they apply force. Despite the application of 58 continuous circular force to the helical tissue anchor, As a result, the distal spike 51 pierces the tissue of the annulus 25 and the helical tissue anchor 58 a helical trace until it is sufficiently helically located at a specific location in the tissue. continues throughout. Distal tissue connector 50 any other tissue connector for applications involving anchorage, the delivery means 42 or any other means of transmission, distal Anchorage 49 to annulus 25 by advancing the tissue connector 50 within the tissue of the annulus 25 makes it easy to attach.

After the helical tissue anchor 58 is helically placed in the tissue of the annulus 25, The physician gently pulls the pipe shaft of the delivery vehicle 42. Towing force of 42 to the vehicle With the application of the annulus tissue, the distal tissue connection is arranged in a spiral manner. pulls element 50 and thus inserts element 47a into the slot 48 of the router 44. separates the anchor 49 from the vehicle 42 by pulling through it. implantable element 47a through slit 48 As it is pulled and slides distally within it, the anchor 49 is released from the guide 44. leaves. The delivery means 42 released from the anchor 49 is then withdrawn within the catheter 40 and catheter 40 through the sheath 34 that remains in place for subsequent advancement of other anchors 49 is removed from within. While removing the catheter 40 with the delivery tool 42, the cord 45 The passage of element 53a remains looped in 56 and is left in place in the sheath 34, so that the proximal end portion 59 of the cord 54 is outside the patient's body and is accessible still exists.

Once outside the patient's body, the delivery vehicle 42 is then attached to a second anchor 49 (anchor 49 connected to the router 44 as described above) and the tool 42 the advancement catheter 40 is fed into the catheter 40, which is reinserted into the sheath 34. second anchor 49 is implanted as described above. All anchors 49 as seen in Figure 3 These steps are repeated until the annulus 25 is implanted around it. As you can see, the cords 45 loosely attached to each of the anchors 49 are contained within the sheath 34 and relevant proximal parts 59 accessible in an area outside the patient's body they are still. Eight anchors 49 around the annulus 25 by way of demonstration and non-limiting implanted, but appropriate for the needs of a particular patient, for example, in a particular Depending on the distention and relaxation level of the patient's annulus, the annulus may be 25 It should be noted that any number of anchors 49 suitable for its circumference can be implanted.

Here, a tube is advanced along the cords 54 into the annulus 25 of the patient's mitral valve. Reference is made to Figure 4, a sematic representation of 60 tissue repair implants. seen such as, the repair implant 60, an intermittent, open portion, by way of demonstration and without limitation. Includes annuloplasty ring. Any cap repair fittings along the cords 54 or implant (for example, a full annuloplasty ring, a partial annuloplasty ring, a prosthesis an insertion for a prosthetic valve, such as a valve or annular valve support member station) can be advanced. 60 of the repair implant, open loop, Any of the techniques described in US Patent Application 12/341,960 to Cabin can be applied using one. Typically, these techniques describe a complete or partial ring. This ring includes: a sleeve, a pulley attached to the sleeve, and the sleeve and a flexible shrinking member attached to the reel so that (1) the shrinking member wrapping it around compresses the ring and (2) pulls the shrink element around the spool. unwinding releases and expands the ring. As can be seen, the implant is a 60 mesh fabric. It contains a permeable manson containing ag. Implant 60 can also be used in addition to or from the sleeve. may independently include a coiled implant.

Reference is made to Figures 20 to 4. Before advancing the implant 60, each of the cords 54 a respective proximal end portion 59 of one is passed through the material of the repair implant 60. For example, end portion 59 (a) is passed through a first surface of implant 60, (b) portion 59 perpendicular to the longitudinal axis defined by the 60 lumen of the implant. It is passed through the 60 lumen of the implant and then (c) proximally to the 60 disc surface of the implant. Obviously, an opposing surface of the implant 60 is passed through it. Implant 60 (sheath 34 through the advancement catheter 40 and through each cord 54 into the annulus 25 A push tool (not shown for the sake of display) is used to advance it correctly. implant When the catheter 60 is exposed through the catheter 40, the pusher is withdrawn and removed from the body. Subsequently, As described below, the implant 60 is in place through the anchors 49 along the annulus 25. is fixed.

Figures 5A-B show a locking mechanism 74 including a lock 80, some of the present invention in this lock 80 connected to several claws 84 that can be opened in the radial direction, in accordance with their application. There is a circular distal portion 82. Diameter of the circular distal portion 82, 1.5 mm to 3 mm between, for example 2.2 mm. The mechanism was found in the vasculature of 74 patients. After advancement, the lock 80 is attached to the implant restraint member 53a, as described below. In a distal region, in a proximal part of the stem 52a of the implanting element 47a, the final is positioned as (Fig. SB).

Lock 80 also proximally from implant 60 anchor 49 and annulus 25. It also functions as a proximal restraint element to prevent it from slipping. should be specified. 11th The locking mechanism 74 is attached to a distal end of an advancement tube 72 and an upper tube It is advanced towards the patient's annulus 25 while it is wrapped with 70. Locking mechanism 74, radial It includes a lock retainer 73 with arms 75 to 77 that can expand in one direction. Collars 75 to 77 each one of which defines a corresponding slot 81 to 83, which slots 81 to 83 are in Figure 5A. as can be seen in the enlarged image, the corresponding parts of the circular distal portion 82 of the lock 80 they understand and receive. Advancement of the locking mechanism into the annulus of 74 patients 25 a portion of the upper tube 70 distal surrounds the arms 75 to 77. Upper pipe 70 in this way It prevents the arms 75 to 77 from expanding in the radial direction, which prevents the gripper 73 and the lock 80 maintains the link between As can be seen, the locking mechanism 74, the advancement tube 72 and the upper tube 70 is advanced along the cord 54 towards the implant 60.

The distal ends of the advancement tube 72 and the upper tube 70 form a proximal end of a portion of the implant 60. are advanced until they come into contact with the surface. In response to continuous pushing of pipes 70 to 72 Additionally, tubing 70 to 72 pushes 60 of the implant distally so that the insertion of the implant member 47a (ie first proximal restraining member 53a then stem 52a) enters implant 60.

For some applications, the proximal restraint 53a pierces a portion of the implant 60 and in the structure that enters it, a needle-like spike is in the form that defines, for example, a hook. Implant 60 when fully pushed in, a distal surface of the implant 60 contacts the tissue of the annulus 25 and The proximal surface of the implant 60 is distal to a distal end of the proximal restraint member 53a. it is located in a row. The handle 52a extends through a lumen of implant 60 to anchor implant 60 49 bags. that the element entering the implant 47a can enter the implant by passing through a braided mesh surrounding the implant, where a coiled implant can enter the implant by passing between its coils and/or It should be noted that it can enter the implant through any penetration.

Figure 5B, after the implant is secured in place at anchor 49 by 60 locks 80. shows the separation of the mechanism 74 from the lock 80. As described below, the lock is attached to 80 anchors. Once connected, the upper tube 70 is slid proximally relative to the advancement tube 72 so that the lock the arms 75 and 77 of the holder 73 are exposed through the distal portion of the upper tube 70 . Arms 75 with 77 exposed, they expand (by their nature) in the radial direction, and the relevant parts of the distal portion 82, free from slots 81 and 83 of the arms 75 and 77, respectively. they are left. When the lock 80 is released from the locking mechanism 74, the advancement tube 72, locking mechanism 74 and upper tube 70 are withdrawn from the patient's body. with retraction Together, the cord 54 is cut and pulled so that the cord is no longer attached to the proximal limiting member. Pass 57a is not looped in 56. Physician cord was removed from 54 patients' bodies. continues to pull the cord until 54. 12 Figures 6A-B to 7 show 60 of the repair implant in accordance with some embodiments of the present invention. shows the method for fixing it to the annulus 25 via anchor 49. As you can see, anchor 49 stem 52a is located from a distal surface of the implant 60 (ie, contacting the annulus 25). surface) to an opposite surface (i.e., the patient's surface) on the proximal surface of the implant 60 It extends through the 60 lumen of the implant up to the surface in contact with the atrium. handle 52a through the 60 lumen of the implant, the distal end of the proximal restraint 53a It extends to lie proximally to its proximal surface. The upper tube 70 (and the advancement tube 72 in the upper tube 70, the locking mechanism 74 and the lock 80) cord 54 towards the anchor 49 implanted in a specific position along the annulus 25 advanced throughout. The distal end of the upper tube 70 is to the proximal surface of the repair implant 49 approaches. Top tube 70 with advancement tube 72, locking mechanism 74 with lock 80 anchor 49 It is pushed into the implant inserting element 47a. Locking as pipes 70 to 72 are pushed mechanism 74 is pushed towards the implant 60 and mechanism 74 moves the lock 80 distally and the circular distal portion of the lock 80 to slide around the proximal restraining member 53a. pushes your part to 82. As the circular distal portion 82 is pushed, the claws 84 proximal restraint member They slide along 53a (Figure 6A).

Typically, in their inactive state, the proximal portions of the paws 84 form a circle in their cross section. they are aligned in such a way that they form, where measured in cross-section (the length of the implant 49 Lt is measured in a plane perpendicular to the longitudinal axis) with the largest dimension 0.25 mm It is between 0.6 mm (for example, 0.45 mm) and its widest cross-sectional area is 0.05 mm2. It is between 0.28 mm2, for example 0.16 mmz. Impression of the proximal parts of the paws 84 that they can be aligned to form a circle through and without limitation, and in the inertial state of the widest cross-sectional area in cross-sections of the proximal parts of the claws 84 Any particular shape between 0.05 mm2 and 0.28 mm2, eg 0.16 mm2 It should be stated that they can be in the form they will receive. 53a of the proximal limiting element claws 84 proximal, as the largest dimension in cross-section is between 0.3 mm and 0.75 mm As it is advanced distally over the limiting member 53a, the proximal limiting member 53a pushes the proximal parts of the claws 84 in the radial direction so that the proximal parts of the claws 84 parts from their inertial state, their widest cross-sectional areas are between 0.33 mm2 and 0.64 mm2, that is, they expand so that the largest dimension in their cross-section is between 0.65 mm and 0.9 mm.

As the proximal parts of the claws 84 are pushed in the radial direction, their total cross-sectional area greater than the widest cross-sectional area of the proximal limiting member 53a.

In response to the continuous pushing of the lock 80 by the locking mechanism 74, the lock 80 84 the respective proximal ends of each distal to the distal end of the proximal limiting member 53a They slide distally until they are positioned (shown in Figure 6B). Sapin 52a is the widest (ie, between 0.03 mm2 and 0.2 mm2) cross-sectional area 53a of the proximal limiting member 13 since it is smaller than the wide (i.e. between 0.07 mm2 and 0.44 mm2) cross-sectional area, the proximal portions of the claws 84 open radially around the handle 52a and thus a widest cross-sectional area smaller than the widest cross-sectional area of the proximal limiting member 53a. They provide cross-sectional area. The widest cross-sectional area of the proximal limiting element 53a is 84 of the claws. greater than the total widest cross-sectional area of its proximal portions at rest. claws 84 proximal because they are large and they wrap around the handle 52a. they are prevented from moving as they are opened around the handle 52a. So, the lock When 80 stalks move proximally along 52a, the proximal end of claws 84 their portions abut against the distal end of the proximal limiting element 53a. In this way, proximal restraining member 53a causes the claws 84 of the lock 80 to slide proximally. so that the proximal restraint 53a, together with the lock 80, It prevents it from slipping proximally from the anchor 49 and from the annulus 25. In this way, the handle 52a functions as a protrusion that protrudes into a plane defined by the implant 60 and distal part of the proximal restraint 53a, protrusion of the proximal part of the implant It acts as a fulcrum, making it easier for him to get angry throughout. proximal limitation above of element 53a (perpendicular to the longitudinal axis from which the length L1 of the implant 49 is measured) transverse section of the abutment, as described with reference to the cross-sectional area (measured in the plane) distance (i.e. cross-sectional area as described above) of the inserting element 47a is greater than the cross-sectional distance.

Additionally, as the lock 80 is pushed distally, the circular distal portion 82 pushes a portion of the implant 60 .

In turn, the implant 60 pushes the circular distal portion 82 so that (1) proximal claws 84 Compression occurs between the parts of it and the distal end of the proximal limiting element 53a, and (2) lock 80 proximal restraint to prevent implant 60 from slipping proximally It is fixed in place according to element 53a.

Figure 7 shows the separation of the lock holder 73 from the lock 80 and from the anchor 49. Top tube 70, lock retracts proximally to expose arms 75 to 77 of the holder 73. Arms 75 and 77, when the upper tube 70 is exposed, they expand in the radial direction, as can be seen, and Relevant portions 82 of the distal circular portion 80, with 81 from slots 75 and 77 of the arms, respectively. 83 are released. Next, the upper tube 70, the advance tube 72 and the lock retainer 73 cord 54 retracts through sheath 34 throughout.

Reference is made here to Figures 20 to 7. Lock 80 implant 60 with anchor 49 proximal by securing it in place between the restraining member 53a, the cord 54 at its proximal end section 59 is cut distally, thus exposing the free ends of the cord 54. More then a first free end of the cord 54 is drawn so that the second free end advancing tube It is pulled through 72 and towards anchor 49. The continuous length of the first free end of the cord 54 in response to the pull of the cord 54 until the cord 54 is disconnected from the anchor 49. 14 its free end is withdrawn through passage 56 of the proximal limiting member 53a. Physician, second the first free end of the cord 54 until the free end emerges again through the tubing 72 continues to pull so that the cord 54 is removed from the patient's body.

Figure 7 is the eight around the annulus 25 of the lock holder 73 of the locking mechanism 74. indicates the separation of the anchor 49 from one. Implantin 60 through anchors 49 and locks 80 method (described above with reference to Figures 5A-B, 6A-B, and 7) It should be noted that it is applied to each of the anchors 49 implanted along the annulus 25. Shape 7, by way of illustration and without limitation, US Patent 12/341,960 to Cabiri The portion described in its application shows implant 60 with a discontinuous ring. For example, any tissue repair device known in the art can be attached via anchor(s) 49. For example, the anchors were inserted into the stomach of 49 patients. implantable and insert a gastric bypass loop into the patient's stomach as described above. can be used to bind in some way.

Figures 8 and 9, in accordance with relevant embodiments of the present invention, through anchors 49 are schematic representations of examples of implant 60 types attached to the annulus 25. Figure 8, including an open, discontinuous annuloplasty ring, by way of demonstration and without limitation The implant shows 60. Figure 9 illustrates, by way of illustration and without limitation, a complete representation of implant 60 shows a system 110 which includes an annuloplasty ring. As explained above, in Figures 8 and 9 the implants shown are illustrated by 60 demonstrations and without limitation and using any tissue remodeling device or implant anchor(s) 49 can be attached to the patient's tissue.

Here, in accordance with some embodiments of the present invention, a distal tissue connection comprising a tissue anchor 121 with element 50 and a proximal element 47b penetrating the implant. Reference is made to Figure 10, which is 120 sematic representations of a system. Element entering the implant 47b includes a proximal flex, which can expand in the radial direction. a tension spring 122 with a proximal restraining member 53b comprising anchor arms 128 .

The implant inserting element 47b includes a proximal portion 124, which proximal portion 124 is attached to the implant. (for example, a tissue repair implant 60) and the implant inserting element 47b It is shaped to define a needle-like pointed tip 126 to facilitate passage over it. Typical As a result, the proximal portion 124, the needle-like cusp 126, and the arms 128 together form a hook 153. they form and function as a hook 158. A proximal flexible part, impression a tension spring 122 as seen through and without limiting (i.e. element 47b) and its length L4 when the spring 122 is released is between 3 mm and 5 mm. between, for example 4 mm. Radially expandable arms 128, anchor 121 It can be compressed and expanded along its longitudinal axis 130. Distal tissue connection element 50 includes a spike 51 that penetrates the distal tissue through the sample and is non-limiting. and in the form that defines a helical tissue anchor 58, for example, tissue connector 50 any suitable tissue known in the art (eg as seen in Figures 19 to 20 below) may contain anchorage.

Anchorage 121 is the proximal inserting element 47b of the anchorage 49 is the proximal inserting element. element 47a is functionally similar, that is, the element that enters both implants is connected to 47a. 47b serves to anchor the implant to tissue and facilitate their attachment. should be specified. In addition, the anchorage 121 of the proximal restraint element 53b of the anchor 49 functionally similar to the proximal limiting element 53a, that is, both proximal Proximally slipping of the restraining element 53a and 53b into the implant and It should be noted that it functions to prevent the separation of 47a and 47 from the entering elements.

As described above, the length of the distal tissue connector 50 L3 is 2-8 mm, for example It is 4 mm. Thus, for some applications, the overall length of anchor 121 L5 is 5-13 mm.

In Figure 10, the flexible portion is shown when the spring 122 is in its relaxed, resting state. Publication 122 in this free state, the length of the flexible part is between 3 mm and 5 mm. spring 122 texture retracted during a stage of repair device implantation. This pull During load, the spring 122 is under load and extends in its relaxed state when under load. the proximal portion of the implanting member 47b through one or more passages 56 in descriptive form. In the configuration shown in Figure 10, only one pass 56 through the passage 56 on the sides of the proximal part 124 of the cord 54 and where the opening is seen. passed must be stated. Cord 54 (as described above with reference to anchor 49) pass 56 It is loosely connected to the anchor 121 by passing it through and the valve repair implant is facilitating correct orientation of 25 implanted tissue anchors 121 at the annulus sees the function. As described above, passage 56 has at least two openings, these are within 1 mm of a proximal end of the inserting element 47b, for example 0.5 mm. the distal portion of the implant insert 47b, the distal tissue connector 50 to the flexible portion. It includes a handle 52b connecting 122. In such an application, the height of the handle 52b is 0.2 mm to 0.4 between mm. Containing distal tissue connector 50 and implant inserting element 47a. the length of the anchor 121 measured along the axis 130 is 6-12 mm, for example 10 mm. The length of the implanting element 47b measured along axis 130 is 4-10 mm, for example ,5 mm. Length of distal tissue connector 50 measured along axis 130 2-8 mm, for example 4 mm. For some applications, the handle 52b includes spring 122 and such a in practice, the length of the handle 52b is between 1 mm and 7 mm.

Figure 11A, in accordance with some embodiments of the present invention, is implanted along the annulus 25. shows many tissue anchors 121 that have been removed. Each of the anchors 121 is attached to an extended transmission vehicle. (not shown for the sake of demonstration) is detachably linked and via tool 16 It is advanced via the transcatheter towards the annulus 25. 58 annulus of the transmission medium helical tissue anchor facilitates its spiral placement into the tissue. 50 of the distal tissue connector for applications involving any other tissue attachment anchorage, the delivery vehicle, distal tissue anchor 121 to the annulus 25 by advancing the fastener 50 into the tissue of the annulus 25 makes it easy to attach.

Each of the anchors 121 is in the magnified image of the tissue anchor 121 in Figure 11A. As can be seen, a proximal end of tissue connector 50 is located within the tissue of the annulus 25. and a distal end portion of the spring 122 will be located proximally to the surface of the annulus 25. is implanted. For some embodiments of the present invention, transmission means 42, above It is loosely attached to each of the anchors 121 as described with reference to Figures 2A-C and facilitates the implantation of each of the anchors 121. In such an application, the implant the arms 128 of the entering element 47b are compressed within the slot 48 of the steerer 44 of the vehicle 42.

When the tissue anchor 121 is implanted, it is described above with reference to the cord 54 attached to the tissue anchor 49. As usual, the cord 54 remains attached to the anchor 121 . By way of demonstration and without being limiting Although eight anchors 121 are implanted around the annulus 25, the needs of a particular patient appropriately, distension and relaxation of, for example, a particular patient's annulus any number of anchors 121 suitable for the circumference of the annulus 25, depending on the level of possible should be specified.

Here, a tube is advanced along the cords 54 into the annulus 25 of the patient's mitral valve. Reference is made to Figure 11B, a schematic representation of the tissue repair implant 60. seen such as, the repair implant 60, an intermittent, open portion, by way of demonstration and without limitation. Includes annuloplasty ring. Any valve repair implant along the cords 54, for example, a full annuloplasty ring, a partial annuloplasty ring, or a prosthetic valve. progress should be made. 60 of the repair implant, the open ring, belongs to Cabiri Any of the techniques described in US Patent Application 12/341.96O can be applied using

Implant 60 along cords 54 as described above with reference to Figures 2C and 4 . is advanced. a push device to push the implant 60 through the catheter 40 and into the annulus 25 (not shown for the sake of display simplicity) is used. of a distal surface of the implant 60 parts 126 of the proximal portion 124 of the implanting element 47b. the implant 60 is pushed until it contacts each of them.

Figure 11C refers to Figure 11B above, in accordance with some embodiments of the present invention. shows a described pusher 140, this pusher 140, anchors 121 being inserted into the implant Each of the elements 47b pushes the respective parts of the implant 60 until they are engaged.

Iome tool 140 as seen along a corresponding cord 54 and into a portion of the implant 60 is advanced. The physician uses the pusher 140 to push the 60 proximal surface of the implant, 17 so that the needle-like tip 126 of the inserting element 47b covers the distal surface of the implant 60 pierces. continuous pushing of the pusher 140: (1) part of the implant 60 around the arms 128 and advances the spring 122 with the flexible portion of the implanting member 47b, thus (2) facilitates the attachment of the implant 60 to the anchor 121. As the implant 60 is pushed, the spring 122 axis 130 It is compressed throughout and provides 120 flexibility to the system while the implant 60 is connected to the annulus 25.

Implant 60 of the distal surface of the implant inserting element 47b igneous proximal spike After puncturing with the tip 126, a proximal portion of the implanting member 47b An opening is formed here for the implant 60 to pass through the distal surface. Implant 60 implants As the entering element is pushed along 47b, as seen in the enlarged image in Figure 11C. The proximal part is located within the 60 lumen of the implant. 47a proximal of the inserting element as the partial passes through the implant 60 and with it (implant 60 is attached to the anchor 121 As the implant 60 is pushed (as seen in the enlarged sectional images) The opening created by drilling the implant 60 material on the 60 distal surface is in the radial direction. It closes around the expandable arms 128 and compresses them in the radial direction. Implant 60 As the partially implanted element 47b is pushed along, the radially expandable arms 128 they are compressed so that they align as well as spring 122. 140 continuous implants with 60 vehicles in response to its being pushed, the igneous proximal tip 126 of the implanting element 47b pierces a proximal surface of implant 60 through the 60 lumen of the implant and the spike 126 is exposed proximally on the 60 proximal surface of the implant.

Here, in accordance with some embodiments of the present invention, the anchor 121 of the implant 60 fixation in a certain position along the annulus 25 by means of its arms 128 Reference is made to Figure 11D, which has a schematic representation. As described above, the implant In response to the continuous pushing of part 60 by the tool 140, the inserting element 47b Its needle-like tip 126 pierces the proximal surface of implant 60 and creates an opening there and exposes through the lumen of the implant 60 proximally to the upper surface of the implant 60.

In response to the continuous pushing of the implant 60 by the instrument 140, the implant 60 the member 47b slides along so that the respective distal ends of the arms 128 are inserted through the lumen of the implant 60 and they emerge through the opening in the proximal surface of implant 60. Arms 128 when the implant 60 is released through the lumen of part 60 (ie, with Iumen 60 and/or implant 60 Compression in the radial direction with the corresponding openings on the proximal and distal surfaces of the ends) arms 128 in the radial direction as seen in the enlarged image in Figure 11D. they expand. The arms 128 are between 0 degrees and 30 degrees with respect to the axis 130 of the anchor 121. They are of radial compression and expansion structure. Arms 128 (1) their proximal ends together to form a circumference larger than the circumference of the 60 outer surface of the implant, and (2) arms 128 around implant 60 to prevent proximal movement of implant 60 they expand to be fixed in place. 18 Reference is made here to Figures 11C-D. Arms around 60 disc surfaces of 128 implants they expand so that implant 60 is proximal along the inserting element 47b. proximal to prevent slipping and implant separation from anchor 60 they function as the limiting element 53b (Figure 11D). Arms 128 extend and anchor 121 When the implant 60 is fixed in place at the annulus 25 through the insertion device 140, the catheter 40 removed from the patient's body. Now the spring 122 is the 60 of the implant applied by the vehicle 140. it is not compressed in response to the thrust and the spring 122 is released to its resting state. returns (Figure 11D). As seen in Figure 11C, the respective implant 60 portions are attached to the anchors. After fastening 121 to the relevant anchor 121, as described above in Figure ZB. Each connected cord 54 is cut and separated from the relevant anchor 121. Typically but essential separation of each of the cords 54 from the anchor 121, (as seen in Figure 11C) etc.) immediately after attaching the respective implant 60 to each of the anchors 121 is performed. Alternatively, the entire implant 60 may be inserted into the annulus via the anchors 121. The cords 54 remain attached to the respective anchors 121 until they are connected.

In some embodiments, with the implant being pushed 140 by 60 tools, the cord 54 is loaded with a 122 load on the spring. is pulled taut so as to be applied, so that the spring 122 expands to a greater length than its length. Release 122, sleeve implant 60 are pulled through the lumen of the arms 128 so that they are exposed through the lumen of implant 60. it helps them out. When the arms 128 are exposed through the implant 60 lumen, the cord 54 is no longer retracted and the arms 128 rest against the proximal outer surface of the implant 60 and to prevent proximal movement of the implant 60 along the inserting member 47b. spring 122 returns to its resting state to allow Thus, arms 128 proximal they function as limiting element 53b and are associated with arms 128, section 124 and spike 124. together they function as a hook 153b. implant 60 to anchors 121 from the leftmost (ie, located at 10 o'clock) anchor 121 in a systematic pattern that starts and moves clockwise from anchor to anchor in series. Revisit Figure 110, which shows the connection by way of illustration and without limitation. reference is made. In accordance with the protocol of the physician performing the operation, the implant 60 in any order suitable for anchors 121 (ie not in series from anchor to anchor) must be specified.

Here, in accordance with some embodiments of the present invention, an open heart or minimal for the implantation of anchors 49 to 121 described above in the invasive procedure. Reference is made to Figures 12-14, which are 200 sematic representations of the system. System 200 one vehicle body 202 and proximal handle portions 204 to 206. Vehicle body 202 is an outer tube it includes shaft 210 and an inner tube shaft 212 (Fig. 14). Inner tube shaft 212 to Figure 2A-C above It functions similarly to the elongated pipe shaft of the transmission medium 42 described with reference. 19 Distal end of tubular shaft 212 to guide 44 described above with reference to Figures 2A-C. it is attached. As described above, guide 44 is loosely attached to anchor 49.

Although Figure 12-14 shows that the router 44 is connected to the anchor 49 guide 44 is also attached to anchor 121 in the manner described above with reference to Figure 11A. must be specified. Proximal end of inner tube shaft 212, vehicle body 202 it is attached to the handle part 206. For some applications, the handle part 206 provides the vehicle body 202 can be rotated along an axis 230 to: (1) the inner tube shaft 212 and thus turning the steerer 44 and thus (2) connecting the anchor 49 to the distal tissue connection. to facilitate helical insertion of element 50 into the tissue of the annulus 25. Alternative As a result, it is necessary to rotate the anchor 49 distal tissue connector 50 and to facilitate helical insertion of the fastener 50 into the tissue of the annulus 25 As a result, the entire vehicle body 202 is rotated about the axis 230 of the vehicle body 202.

In both embodiments, the distal tissue connector 50 spirals into the tissue of the annulus 25. After settling in the figure, anchor 49 it is separated from the router 44 and thus separated from the vehicle body 202.

As seen in Figure 14 , the inner tube shaft 212 is housed within one lumen of the outer tube shaft 210 . Inner pipe shaft 212 and handle sections 204 to 206 each with 49 ties to the anchor they are shaped to provide a lumen for passage 54 of the cord. Through the vehicle body 202, (1) a proximal opening 214 for passage of the cord 54 and (2) a passage for passage 49 of the anchorage through it. distal opening 216. Anchorage 49 distal tissue connector 50 annulus When it is spirally inserted into the tissue and anchor 49 detaches from the router 44, the vehicle body 202 is slid proximally along cord 54, and with anchor 49 22 remains in the heart of the patient.

Figure 15 shows some of the present invention during an open heart or minimally invasive procedure. 22 anchors 49 implanted in the heart of 200 patients indicates its use. In these procedures, an atrial surface of the mitral valve is heart 22 to provide a passage for the distal end portion of the vehicle body 202 to access An incision is made in the left atrium. As can be seen, 49 distal tissue of the anchorage to facilitate helical insertion of the fastener 50 into the tissue of the annulus 25 The vehicle body 202 (or pipe shaft 212) is rotated to As described above, distal helical insertion of tissue connector 50 into the tissue of the annulus 25 The needle-like distal spike 51 pierces the tissue of the annulus 25 for ease of use.

Figure 16 refers to Figures 12-14 above, in accordance with some embodiments of the present invention. As facilitated by the vehicle body 200 in the described system 202, the anchors 49 are helical insertion of one of the distal tissue connectors 50 into the tissue of the annulus 25 with multiple anchorages 49 implanted along the annulus 25. Figure 10*a above and Using the vehicle body 202 of the system 200 of the anchors 121 described with reference to 11A-D It should be noted that it can be implanted through the annulus 25. The vehicle of each of the anchors 49 after implantation through body 202, the respective cords 54 are attached to each of the anchors 49 they remain attached to one another. Attach the patient's proximal ends to the proximal ends of each of the cords 54 accessible from the outside of the body.

As can be seen, each of the distal tissue connectors 50 is located within the tissue of the annulus 25. and each of the proximal restraint members 53a and the shank 52a of each of the anchors 49 they extend proximally from the proximal surface of the annulus 25 . In this way, the proximal each of the Implant inserting members 47a including the restraining member 53a and the stem 52a, along the cord 54, which is loosely attached to the proximal restraining member 53a. Accessible with any tissue repair implant 60 that is advanced correctly.

Figure 17, as described above, in accordance with some embodiments of the present invention. shows the tissue repair implant 60 attached to the annulus 25 through the anchor 49. above description As instructed, the implant 60 is advanced along the cords 54 into the annulus 25 tissue. implantin A means may be used to advance the respective portions 60 along each of the cords 54 .

Alternatively, during an open heart procedure, the physician may remove the relevant portions of the implant 60 uses his fingers to push along each of the cords 54. enlarged in figure 17 As can be seen in the image, a portion of the implant 60 is attached to the anchor 49 as follows: (1) the implant The distal surface of part 60 contacts the proximal surface of the annulus 25, (2) the distal 52a of the stem some of it lies within the 60 lumen of the implant and (3) the 53a of the proximal restraint member. a distal end lies proximal to a proximal surface of the implant 60 portion.

As can be seen, each of the anchors 49 of the respective implant 60 portions After being attached to element 47a, the cords 54 remain attached to the anchors 49.

Figure 18 shows each of the anchors 49 in accordance with some embodiments of the present invention. Relating to a portion of the implant inserting element 47a distal to the proximal limiting element 53a indicates a vehicle system 220 for connecting a lock 80. Vehicle system 220, an inner tube The shaft 226 includes a shaped outer tube shaft 228 that provides a lumen for sliding movement of the shaft. Shape As can be seen in the enlarged cross-sectional image in Fig. 18, the pipe shaft 226 is the 220 of the vehicle system. to facilitate the sliding of the cord 54 along the cord 54 and into the anchor 49 It is shaped to provide a lumen for passage through the satt 226.

The inner tube is a distal end of shaft 226, locking retainer 73 as described above in Figures 5A-B. It is connected to the locking mechanism 74 containing Thus, the inner tube shaft 226 (Figure 5A- Remove the locking mechanism similarly to the advancement tube 72 (described with reference to B). the tube functions to advance distally within shaft 228. Outer pipe shaft 228 (above Similar to the upper tube 70 (described with reference to Figures 5A-B), the locking mechanism 74 21 wrapping the radially expandable arms 75 to 77 and 220 of the system keeping the arms compressed within a distal portion of shafts 75 to 77 functions as. As explained above, the lock holder 73 of the locking mechanism 74 it is loosely attached to the lock 80, which anchors a portion of the 80 implant 60 through the 49 fixes it in place 25 on the annulus.

A proximal portion of the inner tube shaft 226 is connected to a first graspable member 222, the outer a proximal portion of the pipe shaft 228 is connected to a second graspable member 224. First and the second graspable elements 222 and 224, by the hands of the operating physician. they can be grasped. The vehicle system 220 consists of the second graspable element 224 the first graspable element. It is spring loaded to facilitate controlled displacement relative to member 222. Second in response to the retraction of the graspable element 224 away from the first graspable element 22 Finally, the outer tube shaft 228 slides proximally along the inner tube shaft 226.

Before the extraction of the second graspable portion 224, the surgeon performing the operation system 220 (that is, the second intelligible part 224 from the first intelligible part) 222 without pulling further). Thus: (1) distal end of outer tube shaft 228 implant 60 contacts its proximal surface and (2) lock 80, described above with reference to Figures 5A-B, 6A-B, and 7 As drawn, it is pushed along the proximal limiting member 53a and engages the stem 52a. Physician it then pulls the second graspable element 224 away from the first graspable element 222.

In response to the pulling of the graspable element 224 (ie, a towed state of the system 220) As a result, the pipe shaft 228 is withdrawn and a portion of the lock holder 73 distal to the outer pipe shaft 228. exposed distal to the tip. Arms 75 to 77 a distal end of outer tube shaft 228 they are released through it and expand in the radial direction. Next, 80 circular distal portions of the lock 82 is released through slots 81 and 83 of levers 75 and 77 respectively and the lock 80 The mechanism 220 is separated from the vehicle system by its mechanism 74. Proximal restraint with lock 80 implant 60 When secured in place between element 53a, the cord 54 is distal to its proximal end 59. cut as the free ends of the cord 54, and in Figure 2G above. The cord 54 is removed from the patient's body, as described in reference to .

As seen in the enlarged sectional images in Figure 18, a distal portion of the stem 52a, with a first opening on a distal surface of the implant 60 within the implant 60 Lumen. Anchor the implant 60 by positioning it between a second opening on the 60 proximal surface 49 bags.

Here, in accordance with some embodiments of the present invention, the distal tissue attachment member 50 has one or more, eg, multiple claws 326, which can expand in the radial direction. The tissue described above, except that it includes an expandable tissue anchor 322 containing 320 schematic representation of a system containing a tissue anchor 321 similar to anchor 49 22 Reference is made to Figure 19. Claws 326 flexible metal, eg nitinol or They contain stainless steel and are in a radial direction as seen in the leftmost image in Figure 19. they tend to expand. Anchors 322 tissue anchors 321, mitral valve or tricuspid to the annulus of the native valve, such as a valve, or to any other valve or tissue. they make it easy to attach. Tissue anchorage 322 needle-like structure that pierces the annulus 25 tissue It is shaped like a distal pointed tip 324. As described above, this present invention length L3 of distal tissue anchor 50 including tissue anchor 322 for application It is 2-8 mm, for example 4 mm.

The tissue anchor 322 is 52a to the stem 47a of the implanting member as described above. connected (for example, welded or connected by any other means). implantation the length of element 47a L2 is 4-10 mm, for example 5.5 mm. Taken together, the tissue the length of the anchor 321 L1 is 6-18 mm, for example 10 mm.

In the images on the right in Figure 19, the tissue anchor 322 is implanted into the annulus 25 tissue. while it is displayed. The needle-like distal spike 324 pierces the annulus 25 tissue. Anchorage 321 distal In response to being pushed, the tissue anchor 322 is pushed within the tissue of the annulus 25. Anchor 321 as it is pushed, the force of the annulus 25 tissue pushes the claws 326 and (seen in the upper right image) like) claws 326 inwards. After pushing the anchor 321 distally anchor 321 (for example, by pulling the cord 54) is slightly pulled proximally so that radially so that the claws 326 take a flower shape and a larger surface area their expansion in the direction is provided and the proximal movement of the anchor 321 in the annulus 25 tissue is blocked.

After the anchorage 322 is implanted into the annulus 25 tissue, the handle 52a lies proximally to one of its surface, so it can puncture the implant, as described above. and can take.

Figure 20 is described with reference to Figure 19 above, in accordance with some embodiments of the present invention. As described, the distal tissue anchor 50 includes an expandable tissue anchor 322. containing a tissue anchor 421 which is similar to the tissue anchor 121 described above, except shows a system 420. As described above, tissue for this embodiment of the present invention length L3 of distal tissue connector 50 containing anchor 322 is 2-8 mm, for example 4 mm. In addition, as described above, anchor 421, by way of demonstration and limiting includes a proximal flexible portion containing tension spring 122, as seen without bow 122 The length of the element 47b that enters the implant when free is between 3 mm and 5 mm, for example 4 mm. Thus, for some applications, the overall length of the anchor 421 L5 is 5-13 mm.

Tissue anchor 421 with distal tissue connector 50 and proximal implant insert 47b includes. As described above, the implanting element 47b includes the proximal flexible portion, 23 this proximal flexible portion contains anchor arms 128 which can expand in the radial direction. the proximal limiting member 53b and the tension spring 122. Implant insertion element 47b includes a proximal portion 124, which proximal portion 124 attaches to the implant (for example, a tissue repair 60) and the transition of the implant onto the implanting element 47b. To facilitate, it is shaped like a needle 126 defining a pointed tip. Typically, proximal portion 124, needle-like prong 126 and arms 128 together form a hook 153 and they function as a hook 153.

Reference is made here to Figures 19 and 20. For some applications of the present invention, During the delivery of the anchors 321 to 421 towards the annulus 25, the claws 326 position and atraumatic progression of the claws towards the 25 tissues in 326 annulus. a sheath (not shown) wraps the paws 326 for ease.

Reference is made here to Figures 1A-F, 2A-C, 3-4, 5A-B, 6A-B, 7-10, 11A-D, and 12-20.

Any of the systems, methods, and anchors 49, 121, 321 and 421 described herein It can be used on atrioventricular valve, eg mitral valve or tricuspid valve. should be specified. In addition, the systems, methods, and anchors 49, 121, 321 described herein and 421 are suitable for facilitating the implantation of any suitable implant. can be implanted in any tissue site (for example, in the patient's stomach tissue) should be specified.

For certain embodiments of the present invention, the techniques described herein with the techniques described in one or more of the references cited in the Background section of the can be applied together. The following patent and patent application publications may be helpful: . "Mitral Valve treatment", filed March 15, 2006, by Gross et al. Techniques", PCT Publication WO 06/097931 i Gross et al., "Mitral valve closure" deposited December 5, 2006 US Provisional Patent Application 60/873,075 entitled "techniques"; . "Mitral valve closure", filed February 16, 2007, by Gross et al. US Provisional Patent Application 60/902,146 entitled "Techniques"; - "Segmented ring" of Gross et al., deposited on 29 October 2007 US Provisional Application No. 61/001,013 entitled "placement"; "Segmented ring" of 0 Gross et al, deposited December 5, 2007 PCT Publication WO 08/068756, entitled placement“; i Gross et al., "Segmented ring" deposited on 5 December 2007 11/950.930, titled "placement", published US 2008/0262609 US Patent Application; 24 . Maisano et al., filed May 4, 2009, "Adjustable repair titled chords and spool mechanism therefor", as US 2010/0161041 published US Patent Application No. 12/435,291; . "Annuloplasty ring with US Patent Application 12/437,103 entitled "intra-ring anchoring"; - "Annuloplasty" by Gross et al., deposited on 15 June 2009 PCT No. WO 10/004546, entitled "devices and methods ot delivery therefor" Publication; o Maisano et al., "Implantation weed" deposited on September 21, 2009 titled "repair chords in the heart", published US 2010/0161042 US Patent Application 12/548,991; - "Adjustable WO 10/073246, entitled "annuloplasty devices and mechanisms therefor" PCT broadcast; - "Actively-engageable", filed February 17, 2010, by Miller et al. titled "movement-restriction mechanism for use with an annuloplasty structure", US Patent Application 12/706.868, published as US 2010/0211166; i Maisano et al., "Implantation of PCT Patent No. PCT/IL2010/000357 entitled "repair chords in the heart" Application; and/or - "Deployment" of Zipory et al., deposited on 4 May 2010 titled "techniques for annuloplasty ring and over-wire rotation tool", PCT Patent Application No. PCT/IL2010/000358.

The techniques described herein are comparable to the techniques described in one or more of these applications. can be applied together.

Profession in which the present invention is not limited to those specifically illustrated and described above will be greatly appreciated. On the contrary, the inventions/embodiments described its variations and modifications without departing from the scope defined by the claims. erbabinca is open.

Claims (1)

REQUESTS Tissue anchor (49) for use with a valve repair implant (60) that connects to a patient's cardiac tissue, this tissue anchor (49) includes a distal tissue connector (50) that connects the tissue anchor (49) to the patient's cardiac tissue ; The features are: the tissue anchor also includes a proximal implant-engaging element (47a; 47b) in the structure that penetrates at least a portion of the valve repair implant (60) and facilitates the attachment of the valve repair implant (60) to the tissue anchor (49), proximal inserting element into the implant It includes: an implant restraint (53a; 53b) attached to a portion of the implant-receiving element (47a; 47b), the implant restraining element (53a; 53b) of a structure that prevents the valve repair implant (60) from detaching from the implant-receiving element (47a; 47b). The tissue anchor of claim 1, characterized in that the restriction element (53a; 53b) includes a protrusion of a structure that protrudes into a plane of the implant (60) and connects the implant (60) to the tissue anchor (49). Tissue anchorage according to claim 2, characterized in that the protrusion is of a shape defining a distal abutment whose cross-sectional distance is greater than the transverse section distance of the implant inserting element (47a; 47b), this distal abutment facilitates proximal movement of the implant (60) along the protrusion. is in the structure. Tissue anchorage according to claim 1, 2 or S, further comprising a cord (54) that can be solublely attached to the tissue anchor (49), this cord (54) of the implant (60) along the cord (54) and to the tissue anchor (49). ) has a structure that facilitates the correct passage. Tissue anchorage according to claim 4, characterized in that the proximal element (47a, 47b) entering the implant includes a handle (52a; 52b). Tissue anchorage according to claim 5, characterized in that the length of the stem (52a; 52b) is between 1 mm and 7 mm and the widest cross-sectional area is between 0.03 mm2 and 0.2 mm2, which is at least 4 times the square root of the widest cross-sectional area. is final. It is a tissue anchorage according to claim 5, characterized in that the widest cross-sectional area of the implant restraint element (53a; 53b) is at least 1.5 times the widest cross-sectional area of the stem (52a; 52b). The tissue anchor of claim 7, characterized in that the tissue anchor further includes a lock in the structure advanced towards the anchor and located between the implant (60) and the implant restraint member (53a; 53b), the lock comprising: towards the implant (60) a distal part in recumbent structure; and an expandable proximal portion with a cross-sectional area larger than the widest cross-sectional area of the handle (52a; 52b) and smaller than the widest cross-sectional area of the implant restraint member (53a; 53b) during the inertial state of the lock. Tissue anchorage according to any of the preceding claims, characterized in that it includes a hook of a structure that prevents the implant limitation proximal movement. Tissue anchorage according to claim 9, characterized in that the hook includes one or more arms that can expand in the radial direction to abut against an outer surface of the implant (60) after the implant (60) is attached to the implanting element (47a; 47b). Tissue anchorage according to claim 10, characterized in that the arms can be opened in the radial direction during at least part of the attachment of the implant (60) to the element (47a; 47b) entering the implant. Tissue anchorage according to any of claims 9 to 11, characterized in that the proximal element (47a; 47b) penetrating the implant contains a flexible part, which has a structure that offers a first length when free and a second, greater length when under load. Tissue anchorage according to any of the preceding claims, characterized in that the distal tissue connector (50) and the proximal element (47a; 47b) entering the implant are made of one piece. Tissue anchorage according to any of the preceding claims, characterized in that the implant restraint member (53a; 53b) is attached to a proximal part of the implantable member (47a; 47b). Tissue anchorage according to any one of the preceding claims, characterized in that the implant restriction element (53a; 53b) is in a structure that passes through the implant (60). A tissue anchor according to any preceding claim, characterized in that the tissue anchor is for use with a valve repair implant selected from the group consisting of: a complete annuloplasty ring, a prosthetic valve, and a docking station for a prosthetic valve. P5233 TISSUE ANCHORAGE FOR ANULOPLASTY DEVICE Some applications of the present invention relate to tissue anchors in general. More particularly, some applications of the present invention relate to tissue anchors for the repair of an atrioventricular valve of a patient. BACKGROUND OF THE INVENTION Dilatation of the annulus of the mitral valve prevents the valve leaflets from becoming fully cooptive when the valve is closed. Mitral regurgitation of blood from the left ventricle into the left atrium leads to increased total heartbeat volume and decreased cardiac output, and ultimately to a weakening of the left ventricle due to excessive volume and pressure overload in the left atrium. describes methods, which may have proportionally sized partial or full annuloplasty rings, a pair of trigonal sutures or implantable anchors, and pairs of feet sized and shaped for attachment at spaced locations along its length with the ring to reconstruct a heart valve that has become somewhat inadequate. they can use systems with many clamps. These systems allow for relative axial movement between the clamps and the ring, so that a patient's heart valve can be reconfigured in a way that does not prevent minor changes in the native valve components. Clamps with shape memory alloy material may have legs with free ends that engage after implantation. Annuloplasty rings can be complete or partial, and they can be fenestrated. An alternative method is to run a flexible wire, preferably of shape-memory material, through the folds of the pre-implanted clamps. Other alternative systems use shape-memory material fasteners with hook ends to engage with clamps or other implanted supports, which, after implantation, shorten in effective length and clamp or pull the clamps or other supports together to create the desired curvature of the reconstructed valve. These fasteners may be separate from or integrated with the supports and may have various shapes and forms. Many of these systems describe remodeling of this tissue structure by shortening the non-invasively implantable distance using a delivery catheter. The first and second anchor structures are implanted into the first and second portions of the tissue structure, respectively. These anchor structures are connected by a bonding structure, the length of this bonding structure between the anchor structures can be shortened to pull the tissue structure portions towards each other. Each of the anchor structures may contain two screw structures, these screw structures are driven into the transverse portions of the assembled tissue structure to the anchoring structure and with a spacer between the two screws. If desired, the entire prosthesis can be implanted percutaneously. An exemplary use of the prosthesis is to shorten the annulus of the patient's mitral valve while at least part of the prosthesis is implanted in a patient's coronary sinus. The following patents and patent application publications may be useful: PCT Publication WO 07/136783 by Cardledge et al. PCT Publication WO by Gross et al. describes a tissue anchor as in the preamble of claim 1 of the present invention. PCT Publication WO 10/004546 by Gross et al. PCT Publication WO 10/073246 by Cabiri et al. US-5,306,296 to Wright et al. US-6,569,198 Wilson et al. US-6,619,291 of Hlavka et al. US-6,764,510 to Vidlund et al. US-7,004,176 of Lau. US-7,101,395 of Tremulis et al. US-7,175,660 of Cartledge et al. The following articles may be helpful: O'Reilly S et al, "Heart valve surgery pushes the envelope," Medtech lnsight 8(3): Dieter RS, "Percutaneous valve repair: Update on mitral regurgitation and endovascular approaches to the mitral valve," Applications iri Imaging, Cardiac Interventions, Supported by an educational grant from Amersham Health pp. 11-14 (2003) SUMMARY OF THE INVENTION The invention provides a tissue anchor for use with a valve repair implant according to claim 1. Optional features of the invention are set out in dependent claims. In some embodiments of the present invention, a tissue anchor is provided that receives an implant and facilitates its implantation. The anchor includes a distal tissue anchor such as a helical anchor that penetrates a patient's tissue. The anchor also includes a proximal implant-receiving element that receives the implant and facilitates the attachment of the implant to the tissue anchor. The implant-receiving member includes a handle that extends between the proximal tip of the distal tissue connector and the proximal end of the distal tissue connector. For some applications, the proximal tip of the implant-receiving member includes a hook that pierces and receives the implant. Typically, during an open heart, minimally invasive, or transcatheter procedure, multiple tissue anchors are implanted through an annulus of an atrioventricular valve of the patient, and these tissue anchors are of a structure that receives and facilitates the implantation of a valve repair implant, such as an annuloplasty ring or a prosthetic valve. . Each of the anchors is loosely attached to a cord, for example a suture or a wire, at one end of the proximal insertion element. Prior to implantation of the valve repair implant, each cord is threaded through the implant and then the implant is slid along the cords into the annulus. In response to the continuous pushing of the valve repair implant, the implant is then pierced at locations associated with the proximal spikes of each of the implant inserting members. The physician continues to push the valve repair implant so that the implant slides along the inserts and the stems of the anchors. The implant is pushed along the stem until the proximal spikes of each of the implanting elements are exposed through the lumen of the valve repair implant and are located proximally on a proximal surface of the implant. The valve repair implant is then fixed on the implant surface facing the lumen of the patient's atrium. After the implant is fixed, the cords are separated from the anchors and removed from the patient's body. The method of implanting a tissue anchor on an atrioventricular valve repair implant in a patient is within the scope of the invention claimed in the present application. In some embodiments of the present invention, a proximal restraint member, eg, radially extendable arms, is attached to a proximal portion of the anchor stem. This restraint element prevents the implant from separating from the inserting element. In some embodiments of the present invention, a flexible portion is connected, for example, from the proximal end of a tension spring to the proximal tip of the implanting element and from the distal end to the proximal end of the handle. The invention provides a device according to claim 1. In some embodiments of the present invention, the stem is between 1 mm and 7 mm in length and the widest cross-sectional area is between 0.03 mm2 and 0.2 mm2, which is at least 4 times the square root of the widest cross-sectional area. The present invention will be fully understood from the following detailed description of the embodiments of the invention discussed with the drawings, where: BRIEF DESCRIPTION OF THE DRAWINGS Figures 1A-F are schematic illustrations of a procedure for implanting a tissue anchor to receive a valve repair implant, in accordance with some embodiments of the present invention; Figures 2A-C are schematic representations of tissue anchorage and its delivery means, in accordance with some embodiments of the present invention; Figure 3 is a schematic representation of several tissue anchors in Figures 2A-C implanted through a patient's annulus, in accordance with some embodiments of the present invention; Figure 4 is a schematic illustration of the advancement of a valve repair implant into several tissue anchors in Figure 3, in accordance with some embodiments of the present invention; Figures 5A-B, 6A-B and 7 are schematic representations of the respective locking mechanisms for each of the tissue anchors in Figures 3-4, in accordance with some embodiments of the present invention; Figures 8 and 9 are schematic representations of valve repair implant Specimens obtained with tissue anchors in Figures 3-4, in accordance with some embodiments of the present invention; Figure 10 is a schematic illustration of a tissue anchor for receiving a valve repair implant, in accordance with some embodiments of the present invention; Figures 11A-D are schematic representations of a transcatheter procedure for the implantation of multiple tissue anchors in Figure 10, in accordance with some embodiments of the present invention; Figures 12-14 are schematic representations of a guide for implanting the tissue anchors of Figures 2A-C and 10 during a minimally invasive or open heart procedure, in accordance with some embodiments of the present invention; Figures 15-18 are schematic representations of the implantation and fixation of the valve repair implant during a minimally invasive or open heart procedure, in accordance with some embodiments of the present invention; Figure 19 is a schematic representation of the tissue anchor in Figures 2A-C, in accordance with some embodiments of the present invention; and Figure 20 is a schematic representation of the tissue anchor of Figure 10 in accordance with some embodiments of the present invention.